Now more than ever companies manufacturing parenteral products with aseptic filling are urged to look at barrier technologies, either Restricted Access Barrier Systems (RABS) or isolators. This article describes the experience of a company using two types of isolators for aseptic filling of cartridges and syringes and provides some practical recommendations regarding design, qualifications, start-up, and routine operations.The recent COVID-19 pandemic has brought more attention to the pharmaceutical industry as vaccines and monoclonal antibodies have been developed to help fight the pandemic. Vaccines and monoclonal antibodies are parenteral products filled in vials or syringes and produced through aseptic filling without terminal sterilization. Manufacturing these products is complex because of the challenges of aseptic filling. The traditional aseptic filling, considering the concepts outlined in the draft New Annex 1, is not well accepted for new lines, and instead there is a strong push toward implementation of barrier technologies, which in essence means either RABS or isolators.This article will focus on isolator technology, providing some suggestions from 20 years of experience using isolators for aseptic filling (and for sterility testing), with a continuous growth in terms of volume, markets, products, and equipment.
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